510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2265 of 3531

510(k) clearances, page 2265 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924584	Health Essentials Fancy Personal Massager	Conair LLC.	IRO	Class I	1993-10-12
K924583	Health Essentials Multi-Purpose Massager	Conair LLC.	IRO	Class I	1993-10-12
K924582	Health Essentials Body Care Massager	Conair LLC.	IRO	Class I	1993-10-12
K924581	Health Essentials Maxi Massager	Conair LLC.	IRO	Class I	1993-10-12
K924519	Bodytherm	Conair LLC.	IRO	Class I	1993-10-12
K924518	Body Soother	Conair LLC.	ISA	Class I	1993-10-12
K924431	Healtlh Essentials Personal Massager	Conair LLC.	IRO	Class I	1993-10-12
K922608	Endopath Ep Disposable Trocar	Ethicon, Inc	GCJ	Class II	1993-10-12
K922486	Danek Tissue Cutting and Removal System	Sofamor Danek Mfg., Inc.	HRX	Class II	1993-10-12
K922442	Isolation Gowns	Pfb Inter-Apparel Corp.	FYC	Class II	1993-10-12
K922115	Ivac Needleless Injection Valve	Y	FPA	Class II	1993-10-12
K921977	Synergy Screen Test, Modification	Baxter Healthcare Corporation	LRG	Class II	1993-10-12
K921536	Acculyte Chemiluminescence Analyzer	Laboratory Technologies, Inc.	JJQ	Class I	1993-10-12
K921377	P/meter	Zertl Medical, Inc.	DPW	Class II	1993-10-12
K934454	Manhattan II	Argosy Electronics	ESD	Class I	1993-10-08
K934453	3-Channel Clock	Argosy Electronics	ESD	Class I	1993-10-08
K934450	Manhattan 3-Channel	Argosy Electronics	ESD	Class I	1993-10-08
K934449	3-Channel K-Amp	Argosy Electronics	ESD	Class I	1993-10-08
K934448	Power 3-Channel-Clock	Argosy Electronics	ESD	Class I	1993-10-08
K934447	Linear Plus-Power	Argosy Electronics	ESD	Class I	1993-10-08
K934446	Power Manhattan II	Argosy Electronics	ESD	Class I	1993-10-08
K934444	K-Amp	Argosy Electronics	ESD	Class I	1993-10-08
K934443	2:1 Input Compression	Argosy Electronics	ESD	Class I	1993-10-08
K934442	Linear Plus	Argosy Electronics	ESD	Class I	1993-10-08
K933702	Sigma Cx-3 Calibration Standard Level 1	Sigma Chemical Co.	JIX	Class II	1993-10-08
K933635	Stratus Progesterone Flourometric Immunoassay	Baxter Diagnostics, Inc.	JLS	Class I	1993-10-08
K933249	Dynatron 100 Plus	Dynatronics Research Corp.	IPF	Class II	1993-10-08
K933176	Neurotech 2000 (Nt2000)	Bmr Ent., Inc.	IPF	Class II	1993-10-08
K933035	Bcm-600Tx	B C Medical, Ltd.	KPX	Class II	1993-10-08
K932937	Dynatron 800	Dynatronics Corp.	IMG	Class II	1993-10-08
K932506	Ri-Scope (S)	Rudolf Riester GmbH & Co. KG	ERA	Class I	1993-10-08
K932505	Ri-Star	Rudolf Riester GmbH & Co. KG	ERA	Class I	1993-10-08
K932503	Ri-Mini	Rudolf Riester GmbH & Co. KG	ERA	Class I	1993-10-08
K932028	Pd-1400 Pacer/defibrillator	ZOLL Medical Corporation	MKJ	Class III	1993-10-08
K931974	Az 92	A2j, Inc.	IWE	Class I	1993-10-08
K931805	Zoll Pd 5200C Adult Solid Gel Multi-Function Elect	ZOLL Medical Corporation	LDD	Class II	1993-10-08
K931804	Zoll D 5400 Adult Solid Gel Defibrillation Electro	ZOLL Medical Corporation	LDD	Class II	1993-10-08
K931803	5200 Adult Solid Gel Multi-Function Electrodes	ZOLL Medical Corporation	LDD	Class II	1993-10-08
K931781	Jace Tri-Stim Device	Jace Systems, Inc.	IPF	Class II	1993-10-08
K931552	Davol Cardiovascular Autotransfusion Unit	Davol, Inc.	CAC	Class II	1993-10-08
K930605	Applier, Surgical, Clip	Unisurge, Inc.	GCJ	Class II	1993-10-08
K930135	Silicone Rectal Balloon	Cook Incorporated	FEN	Class II	1993-10-08
K926001	Mrt-50A, Mrt-150A	Toshiba America Mri, Inc.	LNH	Class II	1993-10-08
K925754	Econom	Rudolf Riester GmbH & Co. KG	EPY	Class I	1993-10-08
K925753	Uni III	Rudolf Riester GmbH & Co. KG	ERA	Class I	1993-10-08
K925752	Standard	Rudolf Riester GmbH & Co. KG	ERA	Class I	1993-10-08
K925627	Additional Features Esi-3000 Ultrasound Unit	Elscint, Inc.	IYO	Class II	1993-10-08
K925572	Mityvac Dispos-a-Plate Disposable Leg Plate	Neward Enterprises, Inc.	HGM	Class II	1993-10-08
K924996	Flexiflo 60 Nasojejunal Feeding Tube	Abbott Medical	KNT	Class II	1993-10-08
K924844	Bulk Tissue Removal System	L.A.S.E.R., Inc.	HET	Class II	1993-10-08